Senior Software Quality Engineer

About the Role The Senior Software Quality Engineer provides support to Illumina’s software development teams to ensure product software is developed in compliance with Illumina’s policies/procedures and applicable regulatory requirements (e.g., 21 CFR 820, QMSR) and International Standards (e.g., ISO 13485, IEC 62304). The role drives quality activities across programs, ensuring timely execution, compliance, and continuous improvement, and partners with global cross-functional teams to deliver high-quality software. What You'll Do

• Serve as SME in Software Quality Engineering and primary quality partner for assigned projects.
• Provide end-to-end software quality support across the SDLC, owning quality deliverables for assigned areas.
• Collaborate with global cross-functional teams across time zones to ensure alignment and execution.
• Review and approve development deliverables: Software Development Plans, Verification Plans, Validation Plans, Product/Software Requirements, Software Architecture and Design Documents, Test Protocols, Requirement Traceability Matrix, Test Reports, cybersecurity and risk-related documentation.
• Assist teams in determining verification and validation strategies, ensuring alignment with regulatory and quality requirements.
• Participate in and drive software risk management activities throughout the product lifecycle.
• Review and approve software-related orders.
• Participate in design reviews to ensure effective development, transfer, and maintenance of software products across the lifecycle.
• Provide support for software related issues (Complaints, CAPA), including investigation, resolution, and identification of systemic improvements.
• Identify and make recommendations for continuous improvement of the Software Quality Program.
• Assist in the development and delivery of training to employees on quality processes and practices.
• Provide support and guidance with new technologies development (e.g., AI/ML, Cybersecurity, Cloud) as it relates to software systems and tools.
• Support internal and external audits related to product software and software quality processes.
• Contribute to building and scaling Software Quality Engineering capability within the India team, including standardization of processes and best practices.
• Escalate potential risks and issues to management proactively to ensure visibility and timely resolution.
• Support other areas of the Quality System and perform additional tasks as defined by management. What We're Looking For
• 5+ years’ experience in software quality engineering or related role in a regulated industry.
• Working knowledge of IEC 62304, ISO 13485, 21 CFR.
• Strong understanding of software development lifecycle (SDLC) processes and software engineering best practices.
• Experience working in a global delivery model with cross-functional teams across geographies (preferred).
• Ability to independently own and execute quality activities for assigned programs with minimal supervision.
• Ability to operate effectively in a fast-paced and dynamic environment.
• Strong collaboration skills with cross-functional teams (Software Development, Program Management, Product Security, etc.) to drive a culture of quality.
• Good interpersonal, verbal and written communication skills.
• Ability to apply Quality Engineering principles effectively, including structured development processes and risk management.
• Quality and/or Regulatory Certifications (ASQ, AAMI, RAPS, etc.) preferred.
• Experience mentoring or guiding junior engineers preferred.
• Occasional travel may be required.
• Willingness to work in shifts to support the US region (No night shift required). Nice to Have
• Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline.
• ASQ, AAMI, RAPS certifications.
• Experience mentoring or guiding junior engineers. Compensation & Benefits
• We offer a zero-net pay gap in compensation and benefits across gender, ethnicity, or race.
• Inclusive environment with Employee Resource Groups (ERGs) for career development, cultural awareness, and social responsibility.
• Equal opportunity employer with commitment to diversity and inclusion.